Abdominal SurgeryNCT07331441
External Oblique Intercostal Plane Block for Postoperative Analgesia After Major Upper Abdominal Surgery
A study testing External Oblique Intercostal Plane Block and Standard multimodal analgesia in people with Abdominal Surgery and Postoperative Pain, run by Jun Zhang at 1 site in China.
Trial summary
Postoperative pain after laparoscopic major upper abdominal surgery (e.g., gastric, hepatic, gallbladder, pancreatic surgery) is often severe, and inadequate analgesia may lead to increased opioid use, opioid dependence, and poor functional recovery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Abdominal Surgery, Postoperative Pain
- What is being tested?
- External Oblique Intercostal Plane Block and Standard multimodal analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obtain written informed consent from participants or their legal representatives
- Age between 18 and 85 years
- American Society of Anesthesiologists (ASA) physical status classification I-III
- Scheduled for elective laparoscopic major upper abdominal surgery (e.g., gastric, hepatic, gallbladder, pancreatic surgery)
- Expected surgical duration ≥ 2 hours
- Ability to use the intravenous patient-controlled analgesia (IV PCA) system
Who cannot join
- Hepatic disease (liver enzyme levels ≥ 2× the upper limit of normal)
- Renal disease (serum creatinine levels ≥ 2× the upper limit of normal)
- Allergy to local anesthetics or known study-related drugs
- Pregnancy or lactation
- Low surgical incision site (not involving the upper abdominal wall innervated by T6-T10 nerves)
- Coagulopathy or current use of anticoagulant medications
- Opioid use for more than 2 weeks in the past 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Jun Zhang Fudan University Shanghai Cancer Center, 13817153025, snapzhang@aliyun.com
About this study
Official title: External Oblique Intercostal Plane Block for Postoperative Analgesia After Major Upper Abdominal Surgery: A Randomized Controlled Trial
Postoperative pain after laparoscopic major upper abdominal surgery (e.g., gastric, hepatic, gallbladder, pancreatic surgery) is often severe, and inadequate analgesia may lead to increased opioid use, opioid dependence, and poor functional recovery. Current analgesic techniques such as neuraxial block have safety concerns (e.g., hypotension, neurological injury), while transversus abdominis plane (TAP) block is ineffective for blocking the lateral cutaneous branches of intercostal nerves in the upper abdomen. The External Oblique Intercostal Plane Block (EOIB) is a novel regional block technique that has shown promise in reducing postoperative opioids and pain in small-scale studies, but evidence for its use in major upper abdominal surgery is limited. This randomized controlled trial (RCT) aims to evaluate the analgesic efficacy and safety of bilateral EOIB combined with standard multimodal analgesia versus standard multimodal analgesia alone in patients undergoing elective laparoscopic major upper abdominal surgery. The primary outcome is the total postoperative opioid consumption (measured as Morphine Milligram Equivalents, MME) within 24 hours. Secondary and additional outcomes include pain scores (Verbal Rating Scale, VRS), recovery quality (QoR-15 scale), incidence of adverse events, and hospital stay.
Read the detailed description
Postoperative pain after major upper abdominal surgery is common and may delay recovery and increase opioid-related adverse effects. The External Oblique Intercostal Plane Block (EOIB) is a novel fascial plane block intended to improve analgesia for upper abdominal incisions.
This study is a prospective, single-center, randomized, assessor-blinded controlled trial in adults (18-85 years, ASA I-III) scheduled for elective major upper abdominal laparoscopic-assisted surgery (e.g., gastric, hepatic, gallbladder, pancreatic procedures) with expected operative time ≥2 hours and planned use of IV patient-controlled analgesia (PCA). Participants will be randomized 1:1 using a computer-generated, variable block-size sequence with allocation concealment via opaque sealed envelopes. The block-performing anesthesiologist will not collect outcomes; outcome assessors will be blinded to group assignment.
After induction of general anesthesia and before surgical incision, patients in the intervention group will receive ultrasound-guided bilateral EOIB at the 6th rib level using an in-plane technique; 25 mL 0.3% ropivacaine per side. Control participants will receive no regional block. All participants will receive standardized multimodal analgesia including IV PCA, antiemetic prophylaxis (dexamethasone 5 mg; ondansetron as needed), and NSAID use per ERAS practice.
The primary endpoint is total opioid consumption during the first 24 hours after surgery, expressed as IV morphine milligram equivalents (MME), including PCA and rescue opioids. Secondary outcomes include postoperative pain scores (0-10 verbal rating scale) at prespecified time points (including 24, 48, and 72 hours; at rest and with activity as applicable), quality of recovery (QoR-15 at 24/48/72 hours), opioid consumption at 24-48 hours, postoperative nausea and vomiting within 72 hours, intraoperative hemodynamic events, time to first flatus, and postoperative length of stay.
- Conditions
- Abdominal Surgery, Postoperative Pain
- Being tested
- External Oblique Intercostal Plane Block, Standard multimodal analgesia
- Keywords
- External Oblique Intercostal Plane Block, Postoperative Pain, Laparoscopic Surgery, Pain Management, Randomized Controlled Trial
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Oblique Intercostal Plane BlockProcedure or surgery
Also called EOIB
Ultrasound-guided bilateral external oblique intercostal plane block (EOIB) performed after induction of general anesthesia and before surgical incision. Using an in-plane technique at the 6th rib level, 25 mL 0.3% ropivacaine per side is injected between the external oblique muscle and the intercostal muscle. Standard multimodal analgesia is also provided to all participants.
Standard multimodal analgesiaOther
Also called Usual analgesia
Standard multimodal analgesia per institutional ERAS practice, including intravenous patient-controlled analgesia (IV PCA) with opioids and adjunct non-opioid analgesics (e.g., NSAIDs and/or acetaminophen) with antiemetic prophylaxis as needed. No regional block is administered.
| Study group | Role | What they receive |
|---|---|---|
| EOIB Block | Experimental | Participants receive ultrasound-guided bilateral External Oblique Intercostal Plane Block (EOIB) after induction of general anesthesia and before surgical incision, using 0.3% ropivacaine (25 mL per side), in addition to standard multimodal analgesia (including IV PCA and ERAS-based non-opioid analgesics). Receives: Procedure: External Oblique Intercostal Plane Block |
| Usual Analgesia | Other | Participants receive standard multimodal analgesia without any regional block. Analgesia includes IV patient-controlled analgesia (PCA) and other non-opioid analgesics per the institutional ERAS protocol. Receives: Other: Standard multimodal analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption within 24 hours after surgery (IV morphine milligram equivalents, MME)
Cumulative postoperative opioid use from end of surgery to 24 hours postoperatively, including IV PCA opioids and any rescue opioids, converted to intravenous morphine milligram equivalents (MME) and reported in mg.
Measured: 0-24 hours postoperatively (from end of surgery to 24 hours after surgery)
Secondary outcomes (2)
Postoperative Pain Score Within 24 Hours Postoperatively
Pain is assessed using a Verbal Rating Scale (VRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable). Assessments are performed each morning and evening. A difference of ≥1 point between groups is considered clinically significant.
Measured: Within 24 hours postoperatively
Postoperative Recovery Quality at 24 Hours Postoperatively
Recovery quality is evaluated using the QoR-15 scale (a 15-item questionnaire measuring physical comfort, emotional state, and functional recovery). A difference of ≥6 points between groups is considered clinically significant.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Feb 2026
- Primary completion25 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jun Zhang, Fudan University
- Investigators
- Jun Zhang, PhD, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331441
- Sponsor's protocol ID
- 2512335-12
- Status last verified
- Aug 2026
- First submitted
- 28 Dec 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Oblique Intercostal Plane Block for Postoperative Analgesia After Major Upper Abdominal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07331441
- Acronym / sponsor ID
- 2512335-12
- Conditions
- Abdominal Surgery, Postoperative Pain
- Keywords
- External Oblique Intercostal Plane Block, Postoperative Pain, Laparoscopic Surgery, Pain Management, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Jun ZhangUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 25 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative pain after laparoscopic major upper abdominal surgery (e.g., gastric, hepatic, gallbladder, pancreatic surgery) is often severe, and inadequate analgesia may lead to increased opioid use, opioid dependence, and poor functional recovery. Current analgesic techniques such as neuraxial block have safety concerns (e.g., hypotension, neurological injury), while transversus abdominis plane (TAP) block is ineffective for blocking the lateral cutaneous branches of intercostal nerves in the upper abdomen. The External Oblique Intercostal Plane Block (EOIB) is a novel regional block technique that has shown promise in reducing postoperative opioids and pain in small-scale studies, but evidence for its use in major upper abdominal surgery is limited. This randomized controlled trial (RCT) aims to evaluate the analgesic efficacy and safety of bilateral EOIB combined with standard multimodal analgesia versus standard multimodal analgesia alone in patients undergoing elective laparoscopic major upper abdominal surgery. The primary outcome is the total postoperative opioid consumption (measured as Morphine Milligram Equivalents, MME) within 24 hours. Secondary and additional outcomes include pain scores (Verbal Rating Scale, VRS), recovery quality (QoR-15 scale), incidence of adverse events, and hospital stay.
Detailed description
Postoperative pain after major upper abdominal surgery is common and may delay recovery and increase opioid-related adverse effects. The External Oblique Intercostal Plane Block (EOIB) is a novel fascial plane block intended to improve analgesia for upper abdominal incisions.
This study is a prospective, single-center, randomized, assessor-blinded controlled trial in adults (18-85 years, ASA I-III) scheduled for elective major upper abdominal laparoscopic-assisted surgery (e.g., gastric, hepatic, gallbladder, pancreatic procedures) with expected operative time ≥2 hours and planned use of IV patient-controlled analgesia (PCA). Participants will be randomized 1:1 using a computer-generated, variable block-size sequence with allocation concealment via opaque sealed envelopes. The block-performing anesthesiologist will not collect outcomes; outcome assessors will be blinded to group assignment.
After induction of general anesthesia and before surgical incision, patients in the intervention group will receive ultrasound-guided bilateral EOIB at the 6th rib level using an in-plane technique; 25 mL 0.3% ropivacaine per side. Control participants will receive no regional block. All participants will receive standardized multimodal analgesia including IV PCA, antiemetic prophylaxis (dexamethasone 5 mg; ondansetron as needed), and NSAID use per ERAS practice.
The primary endpoint is total opioid consumption during the first 24 hours after surgery, expressed as IV morphine milligram equivalents (MME), including PCA and rescue opioids. Secondary outcomes include postoperative pain scores (0-10 verbal rating scale) at prespecified time points (including 24, 48, and 72 hours; at rest and with activity as applicable), quality of recovery (QoR-15 at 24/48/72 hours), opioid consumption at 24-48 hours, postoperative nausea and vomiting within 72 hours, intraoperative hemodynamic events, time to first flatus, and postoperative length of stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EOIB Block | Experimental | Procedure: External Oblique Intercostal Plane BlockParticipants receive ultrasound-guided bilateral External Oblique Intercostal Plane Block (EOIB) after induction of general anesthesia and before surgical incision, using 0.3% ropivacaine (25 mL per side), in addition to standard multimodal analgesia (including IV PCA and ERAS-based non-opioid analgesics). |
| Usual Analgesia | Other | Other: Standard multimodal analgesiaParticipants receive standard multimodal analgesia without any regional block. Analgesia includes IV patient-controlled analgesia (PCA) and other non-opioid analgesics per the institutional ERAS protocol. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Obtain written informed consent from participants or their legal representatives
- Age between 18 and 85 years
- American Society of Anesthesiologists (ASA) physical status classification I-III
- Scheduled for elective laparoscopic major upper abdominal surgery (e.g., gastric, hepatic, gallbladder, pancreatic surgery)
- Expected surgical duration ≥ 2 hours
Key exclusion criteria (7 listed)
- Hepatic disease (liver enzyme levels ≥ 2× the upper limit of normal)
- Renal disease (serum creatinine levels ≥ 2× the upper limit of normal)
- Allergy to local anesthetics or known study-related drugs
- Pregnancy or lactation
- Low surgical incision site (not involving the upper abdominal wall innervated by T6-T10 nerves)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External Oblique Intercostal Plane BlockAlso: EOIBUltrasound-guided bilateral external oblique intercostal plane block (EOIB) performed after induction of general anesthesia and before surgical incision. Using an in-plane technique at the 6th rib level, 25 mL 0.3% ropivacaine per side is injected between the external oblique muscle and the intercostal muscle. Standard multimodal analgesia is also provided to all participants. | Procedure or surgery | EOIB Block |
| Standard multimodal analgesiaAlso: Usual analgesiaStandard multimodal analgesia per institutional ERAS practice, including intravenous patient-controlled analgesia (IV PCA) with opioids and adjunct non-opioid analgesics (e.g., NSAIDs and/or acetaminophen) with antiemetic prophylaxis as needed. No regional block is administered. | Other | Usual Analgesia |
Primary outcome
Total opioid consumption within 24 hours after surgery (IV morphine milligram equivalents, MME)
Time frame: 0-24 hours postoperatively (from end of surgery to 24 hours after surgery)
Cumulative postoperative opioid use from end of surgery to 24 hours postoperatively, including IV PCA opioids and any rescue opioids, converted to intravenous morphine milligram equivalents (MME) and reported in mg.
2 secondary outcomes
Postoperative Pain Score Within 24 Hours Postoperatively
Time frame: Within 24 hours postoperatively
Postoperative Recovery Quality at 24 Hours Postoperatively
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Abdominal Surgery
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruiting
Nurse-Led Prehabilitation Before Major Abdominal Cancer Surgery
Colorectal Cancer
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Recruiting
Vagal Stimulator to Reduce Nasogastric Tube Use
Nasogastric Tube Intubation
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Zhang, PhD study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Oblique Intercostal Plane Block and Standard multimodal analgesia in people with Abdominal Surgery and Postoperative Pain, run by Jun Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Zhang, PhD (0216417559001, snapzhang@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid consumption within 24 hours after surgery (IV morphine milligram equivalents, MME) (time frame: 0-24 hours postoperatively (from end of surgery to 24 hours after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.